PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC).

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PARAMOUNT Phase III study of maintenance
pemetrexed (pem) plus best supportive care (BSC)
versus placebo plus BSC immediately following
induction treatment with pem plus cisplatin for
advanced nonsquamous non-small cell lung cancer
(NSCLC).

• AuthorsL. G. Paz-Ares, F. De Marinis, M. Dediu,
  M. Thomas, J. Pujol, P. Bidoli, O. Molinier, T.
  P. Sahoo, E. Laack, M. Reck, J. Corral, S. A.
  Melemed, W. J. John, N. Chouaki, A. Zimmerman, C.
  M. Visseren Grul, C. Gridelli
• Date posted Post ASCO 2011

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Study Design
N539 Primary OutcomePFS
Treatment A Pemetrexed 500 mg/m2 q 3 weeks
BSC N359
R
Treatment B Placebo BSC N180
Stage IIIB/IV Non-squamous/NSCLC ECOG 0,1 At
least SD post Cis/Pem
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RESULTS
Treatment A Treatment B p-value
Response Rate () 2.8 0.6 NA
PFS by Investigator (median, mos) 4.1 2.8 0.00006
PFS by IRR (median, mos) 3.9 2.6 0.0002
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TOXICITY

• No grade 3 or4 toxicity gt 5 of patients with
  maintenance Pemetrexed
• No difference in QoL by EQ-5D
• No difference in Drug related death.

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STUDY COMMENTARY

• This is the first trial of induction pemetrexed
  (Cis/Pem) followed by continuous maintenance in
  patient with at least stable to induction chemo
• Study was powered for OS but insufficient events
  at time of analysis
• Median of cycles maintenance pem was 4 with
  range 1-19. 23 received gt 6 cycles
• HR for PFS 0.62 was highly statistically
  significant

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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS

• It is too early to assess the real value of a
  continuous Pemetrexed maintenance approach.
• The 38 improvement in PFS (HR.62) is highly
  statistically significant, but the difference in
  median PFS islt 6 weeks.
• The study is powered for OS and final judgment on
  the value of this strategy should await that
  information.